510(k) Report

Devices descending from K970779

8 later devices reach Osteonics Tibial Tray Screw Hole Plugs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032479Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp.20037—
+2K101032Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc.20100—
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K201611Apex Knee SystemOmnilife Science20210—